PROSPER: A MULTINATIONAL, PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, EFFICACY AND SAFETY STUDY OF ENZALUTAMIDE IN PATIENTS WITH NONMETASTATIC CASTRATION-RESISTANT PROSTATE CANCER

CompletadoFase 3ClinicalTrials.gov

ID: NCT02003924Tipo: INTERVENTIONALInicio: 31 de oct de 2013Fin estimado: 28 de nov de 2025

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to assess the safety and efficacy of enzalutamide in patients with non metastatic prostate cancer.

Elegibilidad

Edad mínima: 18 YearsSexo: MALE

Criterios de inclusión

Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, signet cell, or small cell features;
Ongoing androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) agonist/antagonist or prior bilateral orchiectomy (medical or surgical castration);
Testosterone ≤ 50 ng/dL (≤ 1.73 nmol/L) at screening;
Progressive disease on androgen deprivation therapy at enrollment;
PSA and the screening PSA assessed by the central laboratory (central PSA) should be ≥ 2 µg/L (2 ng/mL:
PSA doubling time ≤ 10 months;
No prior or present evidence of metastatic disease;
Asymptomatic prostate cancer;
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
Estimated life expectancy ≥ 12 months.

Criterios de exclusión

Prior cytotoxic chemotherapy;
Use of hormonal therapy or biologic therapy for prostate cancer (other than approved bone targeting agents and GnRH agonist/antagonist therapy) or use of an investigational agent within 4 weeks of randomization;
Known or suspected brain metastasis or active leptomeningeal disease;
History of another invasive cancer within 3 years of randomization;
Absolute neutrophil count \< 1000/μL, platelet count \< 100,000/μL, or hemoglobin \< 10 g/dL (6.2 mmol/L) at screening;
Total bilirubin ≥ 1.5 times the upper limit of normal;
Creatinine \> 2 mg/dL (177 µmol/L) at screening;
Albumin \< 3.0 g/dL (30 g/L) at screening;
History of seizure or any condition that may predispose to seizure;
Clinically significant cardiovascular disease;
Gastrointestinal disorder affecting absorption;
Major surgery within 4 weeks of randomization;
Hypersensitivity reaction to the active pharmaceutical ingredient or any of the capsule components, including Labrasol, butylated hydroxyanisole, and butylated hydroxytoluene;
Any concurrent disease, infection, or comorbid condition that interferes with the ability of the patient to participate in the trial, which places the patient at undue risk, or complicates the interpretation of data, in the opinion of the investigator or medical monitor.

Intervenciones

drug

Enzalutamide

160 mg by mouth once daily

drug

Placebo

Sugar pill to mimic enzalutamide

Ubicaciones

COIBA(Centro de Oncologia e Investigacion Buenos Aires)

Berazategui, Buenos Aires, Argentina

Centro Medico Austral(OMI)

CABA, Buenos Aires, Argentina

Centro de Urologia

CABA, Buenos Aires, Argentina

Hospital Italiano de Buenos Aires

CABA, Buenos Aires, Argentina

Sanatorio Parque

Rosario, Santa Fe Province, Argentina

Instituto De Oncologia De Rosario

Rosario, Santa Fe Province, Argentina

Clinica Universidad Reina Fabiola

Córdoba, Argentina

Hospital Privado Centro Medico de Cordoba

Córdoba, Argentina

Centro Oncologico Riojano Integral (CORI)

La Rioja, Argentina

Patrocinadores

PrincipalPfizer

ColaboradorAstellas Pharma Inc

ColaboradorMedivation LLC, a wholly owned subsidiary of Pfizer Inc.

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

PROSPER: A MULTINATIONAL, PHASE 3, RANDOMIZED, DOUBLE-BLI... | EligiMed